Title: Clinical Research Associate (CRA) - A
Location: Lake Forest, Illinois
Duration: 12 Months
Primary Job Function
- The Clinical Research Associates manages sites through life of trial and close-out, including, the implementation, coordination and conduct of clinical research activities in compliance with applicable Corporate and Divisional Policies and Procedures under supervision of the Clinical Manager.
Core Job Responsibilities
- Under supervision of the Clinical Manager, responsible for the following:
- Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol.
- Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators and site staff.
- Communication with site staff including coordinators, clinical investigators, and their site staff;
- Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff.
- Source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
- Verification that the investigator is enrolling only eligible subjects/samples.
- Ensures timely collection and review of study and regulatory documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
- Responsible for investigational product accountability and inventory.
- Verification and review of adverse events to confirm accurate data reporting in accordance with the protocol.
- Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
- Timely completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
- Builds and maintains relationships with sites
- Basic knowledge in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).
- Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
- Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study sites, processing CRFs including data cleanup and classification of data, and completion of study summary.
- 0-3 Years Experience Level.
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